Regulatory Affairs Specialist - Healthcare

South West

Dallas, Texas – Movement Search & Delivery   is working with a growing “start up” division of a multi-national healthcare communications company developing a cutting edge platform for in-hospital communications.

What you will do: The Regulatory Affairs Specialist is responsible for coordinating and preparing document packages for regulatory submissions from all areas of company, internal audits and inspections. The position compiles all materials required in submissions, license renewal and annual registrations, recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance, and monitors and improves tracking/control systems. The role ensures regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability, serves as the RA representative on project teams with members of development project teams, and reviews protocols, draft labeling compliance instructions. Additionally, the Regulatory Affairs Specialist submits import/export documents, researches and documents regulatory strategies for new products, and assists the documentation staff, as needed, with the archiving, tracking, and maintenance of electronic and paper Regulatory files and with the establishment, data entry, and maintenance of the regulatory electronic databases.

What you will need: Completed 4 year degree.  Current experience in regulatory affairs. Experience with electrical medical devices, including software and hardware.

What we offer: Honest and transparent representation to our clients…  it’s what we do.

If you have ALL of the required qualifications for this position and are skeptical about sending in a resume to someone you have never spoken with, give us a call. We try to rise above the recruiting rhetoric by giving our contact information in order to provide you as much information as possible. We go to great lengths to work directly with the hiring managers for the positions we represent so our job descriptions truly reflect the needs of the organization.

Please send your resume and current compensation to:

Linda Larsen